Double Blade Shoe F/Unigraft Knife 1 — Class II medical device recall Z-1464-2018
Terminated recall by Ace Surgical Supply Co., Inc., reported 2018-05-02, distributed in CA, MI, OK. The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double b
| Recall number | Z-1464-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ace Surgical Supply Co., Inc., Brockton, MA, United States |
| Recall initiated | 2018-03-28 |
| Classified | 2018-04-20 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2018-09-11 |
| Distributed | CA, MI, OK |
| Countries outside the US | CA, CN |
| Quantity | 6 |
| Lot numbers | M050225 |
Product
Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
Reason for recall
The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1464-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.